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| Name | Class |
|---|---|
| Medical University Innsbruck | OTHER |
| Merz Dental GmbH | UNKNOWN |
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As part of the clinical study, 25 patients each were provided with removable partial dentures with clasps made of PEEK in two centres (University Hospital Heidelberg, Department of Prosthodontics and University Hospital for Dental Prosthetics Innsbruck). The patients were examined over a period of 3 years for the number and type of technical or biological complications and questioned about their oral health-related quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEEK-RPDs | Experimental | Participants with removable partial dentures made of PEEK |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Removable Partial Denture | Device | Integration of removable partial dentures made of PEEK for the treatment of tooth loss. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oral-Health-Related Quality of Life | Improvement of Oral-Health-Related Quality of Life (OHRQoL) after incorporation of removable partial dentures made of PEEK (PEEK-RPDs) by using a short version of the validated "Oral Health Impact Profile" questionnaire with 14 questions (OHIP-G 14). A precise evaluation is obtained by adding up the 14 items with their frequency ("never"=0, "hardly"=1, "now and then"=2, "often"=3 and "very often"=4) up to a total value. This value can range from 0 (no limitation of OHRQL) to 56 (severe limitation of OHRQoL). These data are collected before treatment and 3 months after insertion of the PEEK-RPDs. | 3 months |
| Biological complications | Biological complications (intolerances, damage to the abutment teeth and/or the periodontium, survival of abutment teeth) after incorporation of PEEK-RPDs. Measurement tool: Study report form. These data are collected half-yearly after insertion of the PEEK-RPDs. | 3 years |
| Technical complications | Technical complications (clasp fractures, denture defects) after incorporation of PEEK-RPDs. Measurement tool: Study report form. These data are collected half-yearly after insertion of the PEEK-RPDs. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Stober, Assoc. Prof. | Contact | 004962215636048 | thomas.stober@med.uni-heidelberg.de | |
| Bohn Eva-Marie, Assis. Prof. | Contact | 004962215638665 | eva-marie.bohn@med.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Peter Rammelsberg, Prof. / Head | University Hospital Heidelberg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Heidelberg, Department of Prosthodontics | Recruiting | Heidelberg | 69126 | Germany |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| ID | Term |
|---|---|
| D003832 | Denture, Partial, Removable |
| ID | Term |
|---|---|
| D003829 | Denture, Partial |
| D003778 | Dentures |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |